1. Field Of The Invention
The present invention relates to sheet-like compositions that can be used to form a wide variety of various articles, orthoses or orthopedic devices, all of which articles are easily conformable to any shape of a body part or any portion thereof. The present articles are useful to cover a body part or any portion thereof for the treatment or protection thereof in the fields of orthopedic surgery, sports and sports-related injuries.
2. Description Of The Prior Art
In the field of orthopedic surgery, orthopedic devices or articles such as splints, collars for cervical vertebra, corsets and braces for joints are used to cover and support injured parts of the body. Such devices can be used in the treatment of fractures, distortions and deformities, and particularly for correcting and immobilizing the injured parts. Meanwhile in the field of sports, similarly formed devices are used to protect parts of the body against injuries from external impacts.
From a manufacturing viewpoint, these devices are roughly divided into two categories or groups. Splints constitute the first group and are mainly used for such injuries as those involving fractures or distortions of limbs. Splints, in width and length sufficient to cover the injured parts of the body, are applied against the injured body part and an elastic bandage is wrapped around the circumference of the particular splint for support thereof. Collars, corsets, braces for joints and protectors constitute the second group. That is, according to the shape of the injured body part, or the part of the body to be benefitted with the supporting or protecting article, formed materials are produced in combination with other members such as stretchable fabric materials, belts, hinges, fasteners such as Velcro type fasteners, and the like so that the resultant combination of materials can be easily applied to or removed from the injured body part.
The constituent materials of each of these orthopedic devices needs to be formed into a device conforming to the body part in question. There are a variety of known orthopedic device forming methods in the prior art including a method whereby a laminate made of sheets of semi-hard aluminum and foam material is bent by hand or with tools, such as with a pair of pliers, along and around the injured body part. In addition, devices are formed with cardboard, initially softened by wetting with water, which cardboard is applied to and formed around the injured body part for subsequent drying into a rigid device. Another method of forming orthopedic devices involves impregnating a material comprised of multiple-folded layers of textile tape with gypsum or a water-curable resin. The impregnated material is accommodated in a tube-like cotton knit or a laminate of such layers with foam material, and brought into contact with curing water and thereafter applied to the injured body part as the material is hardened. A further method disclosed in Japanese Unexamined Patent Application Publication No. Sho 83-203155 involves bringing an open-celled foam material impregnated with a highly viscous water-curable resin into contact with water, thereafter applying the moistened material to and around the body part and maintaining the material in contact with the body part as the resin cures. Still further, a method of forming orthopedic devices disclosed in Japanese Unexamined Patent Application Publication No. Sho 83-50074 involves applying a polymerizable material to a fabric which has previously been impregnated with a curing agent, coating the treated fabric with a cover, and curing the fabric and cover composition while shaped in conformity to a body part.
However, all of the materials utilized to form the above-identified devices have significant limitations and drawbacks. For example, orthopedic devices and articles formed with materials which include aluminum sheets or cardboard have the drawback that the finished devices fit poorly to the body part. Water-curable materials with impregnated resins, despite having improved body fit, have many drawbacks because the residual water from the curing process does not sufficiently evaporate, thus leading to such problems as long-lasting dampness, discomfort because of stuffiness during use of the devices, the tendency to cause bacterial growth due to the generation of a favorable environment between the skin and the orthopedic device with appropriate temperature and humidity for promoting bacterial growth, and the tendency to cause an unpleasant odor and dermatitis. Furthermore, since curing agents in general and water-curable resins particularly generate heat when cured, a material comprised of such a resin when applied to the entire surface of a substrate, raises a risk of causing a burn on the skin in close contact with the curing device due to accumulation of such heat from the curing process.